NCT01008904

Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer. PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.

Detailed description

OBJECTIVES: Primary * To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer. Secondary * To evaluate the effect of magnesium oxide on overall quality of life. * To evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses. OUTLINE: Patients receive oral magnesium oxide once daily in weeks 2-5. Patients whose hot flashes are not satisfactorily controlled after 2 weeks of treatment may receive magnesium oxide twice daily in weeks 4 and 5. Patients complete a daily hot flash diary for 5 weeks beginning 1 week before treatment. Patients also complete quality-of-life, symptom, and self-assessment questionnaires at baseline, once weekly during treatment, and at the completion of treatment. After completion of study treatment, patients are followed up for at least 30 days.

Conditions

• Breast Cancer
• Cancer Survivor
• Hot Flashes
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	magnesium oxide	Given PO
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2009-11-06
• Last updated: 2016-06-21
• Results posted: 2014-02-05